1. Field of the Invention
The present invention relates generally to a sleeve, or cover, for a vaginal speculum Preferably, the vaginal sleeve comprises a latex sheath having a small orifice at the distal end thereof. At the proximal end of the sleeve, a flange is adapted to cover the pubic region, the lower part of the abdomen, groin region, inner thighs, and perineum. The flange, among other things, protects and excludes vaginal hair from interfering with the examination process. The present invention improves the physician's visibility during gynecological examination and surgical procedures, removes the need for using other medical instruments, such as retractors, by shoring the walls of the vagina, and labia, from collapse, protects the walls of the vagina, and labia, during gynecological examinations and surgical procedures, and further protects the vaginal region from specula pinching during extraction. The flange and sheath protect the vulva and other covered areas from laser beams and electrical current when they are used in gynecological procedures.
2. Background of the Art
Vaginal specula are well known in the art of medical devices. For example, the bi-valve, duck-billed speculum is the most common device for gynecological examination used by medical professionals practicing in OB-GYN care. A speculum is primarily used to give the examining physician and surgeon an unobstructed view of the vaginal cavity. It is also used to keep the vaginal walls from collapsing during medical procedures, such as LEEP, laser, and cauterization, where damage to the vaginal walls is probable should they come in contact with the laser or electrode used during such gynecological procedures.
Devices for covering/sheathing the arms of a speculum are known to exist. These disclose devices are intended to protect patients and medical professionals from the spread of infectious disease. These sheaths are disposable. For example, U.S. Pat. No. 5,234,966 to Ng, discloses a method and apparatus for sheathing and protecting speculum arms. The Ng apparatus and method obviates the need for cleaning and sterilizing speculum arms after use in vaginal and/or uterine examinations. The sheaths covering the arms are disposable and protect the physician conducting the vaginal examination from contact with body discharges including the possibility of contaminated blood. U.S. Pat. No. 5,460,165 to Mayes discloses another such protective sheath for the speculum arms.
There further exist several known patents in the field of female condoms, for example, U.S. Pat. No. 5,515,862 to Artisi et al., U.S. Pat. No. 5,325,871 to Reddy U.S. Pat. No. 5,209,241 to Hardy and U.S. Pat. No. 5,113,873 to Boarman. Generally, these devices relate to barrier methods of contraception and protection from sexually transmitted diseases. In particular, they disclose types of female condoms, most having an extended shield protecting the area surrounding the genitalia. Further, they are devices that allow the female to control the use of contraception, but unlike the "pill," protect the female from sexually transmitted diseases (STDs). Before such devices were available, the responsibility to protect women from STDs was the men's, a responsibility too often ignored Female condoms are neither intended, nor designed to provide the advantages of the present invention.
While there exist several devices for protecting speculum arms during examination and protecting the vaginal cavity during intercourse, none appear to disclose a method or apparatus that can: improve the physician's visibility during gynecological examinations and surgical procedures; remove the need for secondary instruments during surgery, like retractors, by shoring the walls of the vagina, and labia, from collapse; protect the walls of the vagina, and labia, during examinations and surgical procedures; protect the patient from specula pinching during extraction; and, protect the patient from laser and electrical injuries in the areas covered.
Thus, it can be seen that there is a need for a vaginal sleeve that, when used during gynecological examinations and surgeries, will improve visibility for the medical professional and protect the vaginal cavity and surrounding region from possible injury. It is the provision of such a method and apparatus to which the present invention is primarily directed.